Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

Beckman Coulter Life Sciences today announced the previously communicated global voluntary recall launched in January 2018 related to the FC 500™ Series Flow Cytometers (FC 500), COULTER® EPICS® XL™ and COULTER® EPICS® XL-MCL™ Flow Cytometer with System II Software (together referred to as the EPICS) has been classified as Class 1 by the U.S. Food and Drug Administration (FDA).

Published on: Wed, 21 Nov 2018
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Published on: Tue, 20 Nov 2018
The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Published on: Tue, 20 Nov 2018
In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Published on: Wed, 14 Nov 2018
The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Published on: Wed, 07 Nov 2018 00:00:00 +0100
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Published on: Tue, 30 Oct 2018 00:00:00 +0100
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Published on: Tue, 30 Oct 2018 00:00:00 +0100
The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Published on: Tue, 23 Oct 2018 00:00:00 +0200
Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Published on: Tue, 16 Oct 2018 00:00:00 +0200
The duration of the vaccination campaign sufﬁcient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufﬁcient to eliminate LSD vir...

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

The Food and Drug Administration is advising consumers not to purchase or use Black Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

The Food and Drug Administration is advising consumers not to purchase or use Krazzy Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

The Food and Drug Administration is advising consumers not to purchase or use Gold Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

The Food and Drug Administration is advising consumers not to purchase or use Platinum Rhino 25000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

The Food and Drug Administration is advising consumers not to purchase or use Black Stallion 35000, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Mini Cookies with Caramel Flavor”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Melanie Wholesale Inc. of Brooklyn, NY is recalling its 17.6 oz (500g) package of “Melanie Liubitelskie Cookies”, because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Use of products with the undeclared active ingredients, sildenafil and tadalafil, may pose a threat to consumers because the active ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are the most at risk from these products. These products are considered ta...

AMA Wholesale Inc. (Distributor/Re-seller), is voluntarily recalling Rhino 69 Extreme 50000 capsules to the consumer level. FDA analysis found the product to be tainted with undeclared tadalafil. Tadalafil is an active ingredient in a FDA-approved prescription drug that is used for erectile dysfunction.

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Extreme 50000, a product promoted and sold for sexual enhancement on various websites, including www.bonanza.com, and possibly in some retail stores.

A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.